Intermittent catheterization is a good option for many who suffer from various abnormalities of the urinary system. Those with such abnormalities often find it desirable to use individually packaged, sterile catheters. Important criteria for such a single use product include the cost and ease of use in performing intermittent catheterization.
With regard to both cost and ease of use, these factors apply to both the catheter and the package for the catheter. Thus, it is important that end users find these criteria to be acceptable to enhance the desirability of intermittent catheterization.
Current intermittent catheters are packaged in such a way that the end user is usually required to touch the catheter in order to insert it into the urethra. It is notable in this connection that intermittent catheters are commonly provided with a surface treatment using a lubricant to reduce friction in order to allow for easier, less traumatic insertion and withdrawal. Currently, there are two major categories of intermittent catheters having lubricated surfaces, i.e., gel coated catheters and hydrophilic coated catheters.
Gel coated catheters are made easier to insert by having the user apply a gel to the catheter surface, or more conveniently, the gel can be supplied with the packaged catheter. Typically, a system may be provided with the packaged catheter in order to assist in applying the gel to the catheter surface. This system may be one where the gel is put onto the catheter surface just before or during the packaging operation, or one where the gel is applied to the surface as the catheter is being inserted by the user.
In a hydrophilic coated catheter, the catheter is typically provided with a thin hydrophilic coating which is adhered to the outer surface of the catheter for activation by contact with a hydrating liquid such as liquid water or saline solution. When the coating is activated by contact with liquid water or saline solution, it becomes slippery, creating a catheter surface that has an extremely low coefficient of friction. The most common form of this product is a sterile, individually packaged single use catheter provided in a dry state or condition. The user typically exposes the coating to contact with liquid water or saline solution, waits approximately 30 seconds or more, and then removes the catheter from the package in a condition in which it is ready for insertion. The waiting time of approximately 30 seconds or more during which the liquid water or saline solution is in contact with the coating is necessary to accommodate an induction period for activation of the coating. During the induction period, as the hydrophilic coating is activated (for example by soaking the catheter in liquid water or saline solution), the hydrophilic coating swells and causes the catheter surface to become lubricious.
In one version of the hydrophilic coated catheter, it is provided in a package that already contains enough loose liquid water to cause it to be fully immersed so the user need only open the package and remove the catheter ready for insertion without the need to add liquid water or saline solution and wait 30 seconds or more. Other new products provide the amount of liquid water or saline solution necessary for immersion of the catheter in a separate compartment of the package. With these products, one must open the separate compartment allowing the liquid water or saline solution to enter the catheter-containing chamber for direct contact with the hydrophilic coated surface. Depending on the characteristics of the product and packaging, and on the amount of liquid water or saline solution in the separate chamber, the user may be asked to manipulate the package to bathe the catheter surface in the hydrating liquid in order to activate the hydrophilic coating on the catheter surface.
In all of these existing hydrophilic coated catheter products, proper lubrication of the catheter depends upon direct contact of liquid water or saline solution with the entirety of the hydrophilic coated catheter surface for a definite period of time following which the catheter can be removed from the package ready for insertion into the urethra by the user.
With regard to both gel coated catheters and hydrophilic coated catheters, the package is important. The package must be formed of a material and in a manner which is sufficient to hold the gel coated catheter and gel, or the hydrophilic coated catheter and liquid water, for a commercially acceptable shelf life. This means that the package must hold these respective products with little or no deterioration to either the catheter or its lubricant for a period of time that renders the packaged catheter commercially acceptable. Typically such a package is formed of two sheets of a suitable material which hold the gel coated catheter and gel or the hydrophilic coated catheter and liquid water between them. The two sheets of material are conventionally secured together with an adhesive or by welding to form a seal that extends entirely about the perimeter of the package. With this understanding of available catheter packages, there is an important criterion that has yet to be satisfactorily addressed.
In particular, it is well known that many users of intermittent catheters are persons possessing a limited degree of manual dexterity. Thus, it is imperative that the package can be opened easily by the end user of either a gel coated, or a hydrophilic coated, catheter while also minimizing any risk of the gel contacting the user's hands or clothing or of the liquid spilling from the package. The present disclosure avoids these problems in a highly advantageous catheter package and method of forming same.